Active Implants, LLC has received Breakthrough Device Designation from the FDA for its meniscus replacement device.
In a September 19, 2019 press release, the company said the designation will allow for an expedited review of the NUsurface Meniscus Implant and, if eventually approved, make it the first artificial meniscus in the U.S.
The FDA program was designed to speed up the process of getting new technologies to patients with life-threatening or irreversibly debilitating conditions.
Active Implants President and CEO Ted Davis said he believes the company will have the data required for an FDA submission next year, after completing enrollment in clinical trials in 2018.
The meniscus is a tissue pad between the thigh and shin bones. The company says current treatment for a damaged or torn meniscus includes pain management, physical therapy, injections, repair techniques or meniscectomy. “It has been estimated that from 700,000 to over 1 million partial meniscectomies are performed annually in the U.S. in an attempt to alleviate pain; however, studies have shown that many people who get a meniscectomy continue to experience pain that impacts their quality of life and can eventually lead to knee replacement surgery.”
According to the company, the implant is a meniscus replacement in patients with persistent knee pain following medial meniscus surgery. “Meniscus replacement has the potential to fill the gap between minimally invasive meniscus repair and total knee replacement.”
The implant is made from a medical grade plastic called, polycarbonate-urethane. As a result of the implants materials and composite structure and design, the company says the implant does not require fixation to bone or soft tissues. “The NUsurface Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint.”
The implant has been used in Europe under CE Mark since 2008 and Israel since 2011. The SUN and VENUS U.S. clinical trials completed enrollment in June 2018, and Active Implants is expecting to file for regulatory approval in the U.S. in the next two years.
Available in VA?
Both my knees are bone on bone, I know knee replacement is not for me. I am 70 years old and retired chef and retired Army. I would love to participate in this trial. I have been using a Walker and wheelchair for over 10 years. If my pain could be significantly reduced by the artificial meniscus implant and I would have greater mobility..it would be such a blessing. Please help.
I was a runner and a very aggressive skier. I can barely walk now. My medial miniscus in my left knee is gone. I am 66 years old and been running and skiing for over 40 years. Went I retired, I thought all I was going to do was run and ski. I spent just all of the past year with my leg raised with ice and eating Advils. I could do with limited running if I could only ski. When will NUSurface be available in NJ.
I contacted the FDA about a year ago and asked them since they’ve been using the implants in Europe since 2008, and Israel since 2011 why can’t they “fast track” the approval. The reply I got was, quote: We are not permitted to comment on ongoing trials of any medical device or drug. Thank you for your contacting the FDA”. Now that was a big help. I’ve had one knee replaced and two meniscus clean outs on the other. Sure would like an approval and marketing on this replacement
Who is doing a meniscus transplant in Ohio. Are they still accepting candidates?
I cannot walk more than 1 block and sleeping is impossible. I take medication to sleep and most nights I in tears with the severe pain.
Please let me as this is a workman’s comp injury. Need this surgery.
Thanks,
Suzanne
Will this work if you are bone on bone? And when do you expect it to be in use in the US ?
A youthful 66 year old I had right meniscal surgery in 2014, am now experiencing pain on the medial side of the knee. The meniscus would certainly eliminate that pain for me when it is approved. I would greatly be appreciative if I am notified of its progress. Thank you
Hi , i need to know more info about meniscus implant ,because i have a lot of pain in my knee and i have done 2 operation on the meniscus i have torn meniscus, I’m 52 yo.
And if this treatment has been approved from FDA , i will do it.
Could you please let me know the name of the hospital that will start using this technology .